EPHEDRINE HYDROCHLORIDE Tablet (2015)
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Περιεχόμενα
Name of the medicinal product
Ephedrine Hydrochloride 15mg Tablets.
Qualitative and quantitative composition
Ephedrine hydrochloride 15mg. For excipients see 6.1.
Pharmaceutical form
Tablet. White, circular tablets marked E15 on one face and CP on the reverse.
Therapeutic indications
Ephedrine tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma.
Posology and method of administration
Adults 15–60mg three times daily. Children under 1 year: not recommended. 1–5 years: 15mg three times daily. 6–12 years: 30mg three times daily. Elderly Dosage should be substantially reduced. Initial ...
Contraindications
Ischaemic heart disease. Hypertension. Thyrotoxicosis. Prostatic hypertrophy. Ephedrine has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic ...
Special warnings and precautions for use
Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment. Ephedrine has potentially life threatening effects in its acute cardiovascular ...
Interaction with other medicinal products and other forms of interaction
Other adrenoceptor stimulants Concurrent use of ephedrine with theophylline may result in increased nausea, nervousness, and insomnia. Anaesthetics There may be an increased risk of arrhythmias when used ...
Pregnancy and lactation
The use of ephedrine in pregnancy should be avoided as ephedrine crossed the placenta and this has been associated with an increase in foetal heart rate and beat to beat variability. Ephedrine is excreted ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
The most common side-effects of ephedrine are tachycardia, anxiety, nausea, restlessness and insomnia. Tremor, dry mouth, impaired circulation to the extremities, hypertension, headache and cardiac arrhythmias ...
Overdose
Symptoms The symptoms of overdose are normally seen as nausea, vomiting, hypertension, fever, palpitations, tachycardia, restlessness, respiratory depression and convulsions. Paranoid psychosis, delusions ...
Pharmacodynamic properties
Ephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. When given by mouth in therapeutic doses, ephedrine constricts the peripheral vessels, thus increasing blood ...
Pharmacokinetic properties
Ephedrine is rapidly and completely absorbed after oral administration and extensively distributed throughout the body with accumulation in the liver, lungs, kidneys, spleen and brain. Peak plasma concentrations ...
Preclinical safety data
Studies in mice have shown that the lethal toxicity of ephedrine is increased by elevation of body temperature. Ephedrine induces acute locomotor stimulatory activity in rats and mice. The estimated lethal ...
List of excipients
Lactose Maize starch Acacia spray-dried Stearic acid Magnesium stearate
Incompatibilities
None known.
Shelf life
<u>Polypropylene and polyethylene containers:</u> Three years. <u>Blister strips:</u> Two years.
Special precautions for storage
Do not store above 25°C. Store in the original container in order to protect from light.
Nature and contents of container
Polypropylene or polyethylene containers with tamper evident closure. Each pack contains 28, 30, 56, 60, 84, 90, 100, 250 or 1000 tablets. Blister strips of 28, 30, 56, 60, 84, 90 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom
Marketing authorization number(s)
PL 29831/0085
Date of first authorization / renewal of the authorization
26/03/2007
Date of revision of the text
06/10/2015
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